Rivaroxaban granule
Rivaroxaban Granule is a generic prescription medication manufactured by Lupin Pharmaceuticals, Inc., used as an anticoagulant to prevent blood clots. It comes as an oral suspension (1 mg/mL strength) for patients who may have difficulty swallowing pills. Approved under ANDA218195, it will be available starting September 29, 2025. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | Rivaroxaban Granule is a generic prescription medication manufactured by Lupin Pharmaceuticals, Inc., used as an anticoagulant to prevent blood clots. It comes as an oral suspension (1 mg/mL strength) for patients who may have difficulty swallowing pills. Approved under ANDA218195, it will be available starting September 29, 2025. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Rivaroxaban granule",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Rivaroxaban granule — ANDA 218195 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218195"
}
]
|
| identifier | ANDA218195 |
| issued | 2016-09-16 |
| keyword |
[
"fda",
"health-care",
"medications",
"pharmaceuticals",
"prescription-drugs"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Rivaroxaban granule |
